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U.S. Department of Health and Human Services

Class 2 Device Recall APEX (OMNIlife Science, Inc.)

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  Class 2 Device Recall APEX (OMNIlife Science, Inc.) see related information
Date Initiated by Firm June 09, 2015
Date Posted August 24, 2015
Recall Status1 Terminated 3 on September 28, 2015
Recall Number Z-2454-2015
Recall Event ID 71470
Product Classification Guide, surgical, instrument - Product Code FZX
Product Offset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022

Product Usage:
The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems
Code Information Lot Numbers: MM0314R, VA0713, Z1111
Recalling Firm/
Manufacturer		 Omnilife Science Inc.
50 Oconnell Way Ste 10
East Taunton MA 02718-1394
For Additional Information Contact Matthew Nowland
774-226-1841
Manufacturer Reason
for Recall		 The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur.
FDA Determined
Cause 2		 Device Design
Action Omni sent an Urgent Medical Device -Field Safety Notice letters to their customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to Return the attached Acknowledgement and Receipt Form by FAX to 508-819-3390.
Quantity in Commerce 15
Distribution Worldwide Distribution - US Nationwide in the states of OK, CO, OH, MA and the countries of Spain and Australia.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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